Adjuvant, External Oblique Intercostal Plane Block, Ketamine, Pain, Thoracotomy
Conditions
Brief summary
The aim of this study is to evaluate the role of ketamine as an adjuvant in external oblique intercostal plane block for post thoracotomy pain.
Interventions
DRUGKetamine
Patients will receive 29 ml bupivacaine 0.25% + 1 ml ketamine (50 mg).
DRUG29 ml bupivacaine 0.25% + 1 ml saline
Patients will receive 29 ml of bupivacaine 0.25% + 1 ml of saline.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * Both sexes. * American Society of Anesthesiology (ASA) physical status I-III. * Scheduled for open thoracotomy.
Exclusion criteria
* Patients with neurological or intellectual disability. * Infection at the injection site. * Opioid addiction. * Allergic reaction to local anesthetics. * Coagulation abnormalities. * Drug abuse. * Pregnancy. * Severe liver and/or renal failure. * Severe cardiovascular problems.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to the 1st rescue analgesia | 48 hours postoperatively | Time to the first request for the rescue analgesia will be recorded from end of surgery to first dose of morphine administrated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative fentanyl consumption | Intraoperatively | Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain). |
| Mean arterial pressure | Till the end of surgery (Up to 2 hours) | Mean arterial pressure will be recorded preoperatively, before performing the block, and every 15 min till the end of surgery. |
| Degree of pain | 48 hours postoperatively | Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at 0, 4, 8, 12, 18, 24, 36 and 48 h postoperatively. |
| Heart rate | Till the end of surgery (Up to 2 hours) | Heart rate will be recorded preoperative, before performing of block, and every 15 min till the end of surgery. |
| Incidence of adverse events | 48 hours postoperatively | Incidence of adverse events such as pneumothorax, local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication will be recorded. |
| Total morphine consumption | 48 hours postoperatively | Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS) \> 3 to be repeated after 30 min if pain persists until the NRS \< 4. |
Countries
Egypt
Outcome results
None listed